Catalog Number 09038078160 |
Device Problem
High Test Results (2457)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/16/2023 |
Event Type
malfunction
|
Event Description
|
There was an allegation of questionable elecsys vitamin d assay results for 1 patient sample on a cobas e 411 immunoassay analyzer.The initial vitamin d result was >120 ng/ml with flag.The sample was repeated as the customer has an internal policy to repeat all vitamin d results above 120 ng/ml.A 1:2 manual dilution was made of the sample and the result was 74 ng/ml.A second 1:2 manual dilution was made of the sample and the result was 62.66 ng/ml.The repeat result of 62.66 ng/ml was deemed correct.
|
|
Manufacturer Narrative
|
The analyzer serial number is (b)(6).The field service engineer (fse) replaced the mixer motor and performed mechanical checks.The investigation is ongoing.
|
|
Manufacturer Narrative
|
Calibration was last performed on (b)(6) 2023.The qc recovery data provided was not acceptable on the day of the event.The alarm trace did not contain a conspicuous event.It was found that the customer centrifuges patient samples for 5 minutes, which may be too short.The customer stated that there was fibrin present in the patient sample.The customer performed calibration and qc successfully after the field service engineer visit.No further issues were reported after the service visit.The investigation did not identify a product problem.The root cause of the event was found to be consistent with pre-analytical sample handling issues.
|
|
Search Alerts/Recalls
|